3. MANAGER – LABORATORY SERVICES (x 01)

Grade: ZMS 04

Reports to: Senior Manager – Standards and Quality Assurance

Main Job Purpose

To ensure that all operations meet the highest standards of quality, safety and compliance in order to maintain the integrity and efficacy of medicines and medical supplies throughout the supply chain, thereby safeguarding public health and upholding regulatory requirements.

Main Responsibilities

The main duties and responsibilities for this post are but not limited to the following:

1. Policy and Strategic Planning

• Manages the development, review and implementation of policies and strategies in order to ensure adherence to statutory provisions, standards and industry best practices.

• Contributes to the development and implementation of strategic plans for laboratory functions in order to align with organisational goals and objectives and meet customer demands.

2. Inspection, Testing and Validation

• Collaborates with the Manager – Quality Assurance in coordinating the visual inspection of samples for each consignment of medical products received.

• Manages the testing and validation of products and processes in order to ensure that they meet quality specifications and performance standards and maintain product efficacy and safety.

• Ensures that products which cannot be tested by the Agency’s laboratory are tested by accredited outsourced laboratories in Zambia and in the region.

3. Test Methods, Equipment Calibration and Reagents

• Manages the formulation and validation of laboratory test methods and makes decisions on their acquisition.

• Manages the internal and external calibration of laboratory equipment and the maintenance of records of all such activities.

• Manages the sourcing of laboratory reagents from suppliers.

4. Standard Operating Procedures and Quality Control

• Manages the development and implementation of laboratory Standard Operating Procedures (SOPs) and ensures that laboratory staff are trained on them.

• Formulates and recommends quality control policies and reviews quality control and instrument calibration procedures.

5. Monitoring, Reporting and Certification

• Monitors laboratory turnaround times and manages the preparation of reports and the certification of analysis based on analytical results.

• Manages the preparation of Certificates of Analysis (COAs), the submission of investigation reports and the timely preparation of quality complaints reports.

6. Training and Development

– Manages the development and delivery of training programmes on good laboratory practice, in liaison with Human Resource and Administration, in order to ensure that all employees are knowledgeable about quality standards and procedures.

7. Leadership and Management

• Provides leadership to the laboratory teams in order to foster a culture of excellence, teamwork and continuous improvement and achieve performance targets.

• Manages the timely preparation of unit budgets in order to facilitate programme implementation.

• Manages the monitoring and evaluation of Key Performance Indicators (KPIs) in order to measure the effectiveness and efficiency of service delivery and provide appropriate interventions.

• Manages the development of work plans and implementation of the Performance Management System (PMS) in order to monitor, evaluate and enhance performance.

• Manages human, financial and other resources in order to facilitate achievement of unit objectives.

PERSONAL ATTRIBUTES

• Integrity

• Tact and Diplomacy

• Results-oriented

SKILLS REQUIRED

• Leadership and team building skills

• Metrics-driven leadership

• Analytical skills

• Interpersonal skills

• Good computer skills

• Ability to write strategic and technical reports

• Ability to communicate effectively in English

MINIMUM QUALIFICATIONS AND EXPERIENCE

• Full Grade 12 School Certificate

• Bachelor’s Degree in Chemistry, Pharmacy or its equivalent

• Minimum 6 years’ relevant work experience